Ossur Americans (Formerly the Jerome Group)
Country not established
- Devices
- 1
What Ossur Americans (Formerly the Jerome Group) makes
Ossur Americas manufactures orthopedic surgical instruments, including bone-cutting tongs for limb alignment and osteotomy procedures. The product line covers small/medium and medium/large tongs, as well as specialized models like the JT-200D and JT-100D, designed for precise bone manipulation during surgical interventions.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. The company’s products are listed in the FDA’s 510(k) database, reflecting their compliance with US medical device regulations. Ossur Americas operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ossur Americans (Formerly the Jerome Group) have in the registry?
The registry currently lists 1 device for Ossur Americans (Formerly the Jerome Group). Devices recorded under merged duplicate company entries are counted once.
Which registries list Ossur Americans (Formerly the Jerome Group)'s devices?
Among its 1 most recently registered device, Ossur Americans (Formerly the Jerome Group) has devices listed in FDA 510(k) (1 device).
What risk classes do Ossur Americans (Formerly the Jerome Group)'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ossur Americans (Formerly the Jerome Group)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ossur Americans (Formerly the Jerome Group) in the registry?
The most recently registered devices listed for Ossur Americans (Formerly the Jerome Group) include RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D.